Gilead to combine GS-7977 and GS-5855 into a single pill...

Posted 7/27/12 on Bloomberg.com. Gilead doing exactly what they do best, and that is co-formulation. Now it's clear why they avoided a partnership with BMS in spite of a 100% SVR rate - not only do they have their own nuc and NS5A inhibitor, they want to make them one pill. Brilliant. Both the investment and drug development worlds will be watching this particular trial very closely I suspect.

Gilead’s Single Pill Hepatitis C Study Targets 2014 Approval

Bloomberg, By Michelle Fay Cortez and Ryan Flinn on July 27, 2012

Gilead Sciences Inc. (GILD) (GILD) said it plans to start a combination study of two drugs in a single pill to treat hepatitis C by the end of the year, putting it on track to request U.S. regulatory approval for the medicine in 2014.

Gilead, which spent $10.8 billion to acquire one of the medicines, GS-7977, plans to combine it with another, GS-5855, in a trial of 800 patients starting in the fourth-quarter, said Norbert Bischofberger, chief medical officer of the Foster City, California-based company, in a conference call yesterday. If the combination is effective, the company could apply for regulatory approval in the middle of 2014, Bischofberger said.

Gilead is among several drugmakers racing to develop new hepatitis C treatments that act more quickly with fewer side effects than the current standard of care. The goal is to provide doctors and patients with simpler, more effective treatments, Bischofberger said.

The company aims for a therapy that "will clearly be a one pill, once daily, maybe a 12 week course," for patients with all different types of hepatitis C, Bischofberger said. "That's our goal. We are very close."

Conventional therapy combines ribavirin with interferon, an injected immune-boosting protein that can cause flu-like side effects, for as long as 48 weeks.

Gilead is competing with Abbott Laboratories, Bristol-Myers Squibb Co., Johnson & Johnson, Merck & Co. and Vertex Pharmaceuticals Inc. (VRTX) (VRTX) to develop a new generation of hepatitis C treatments. Rising deaths among baby boomers from hepatitis C prompted U.S. health officials to declare in May that the entire age group is at risk and should be tested for the disease.

Gilead Sciences posts good news on PSI-7977...

Posted 2/2/12 on Businessweek.com - PSI-7977 + Ribavirin in genotype 1 looking good four weeks in. Expect full data explosion at CROI next month.

Gilead Gains on Positive Data From Experimental Hepatitis C Drug
February 02, 2012, 8:47 PM EST
By Ryan Flinn

Feb. 2 (Bloomberg) -- Gilead Sciences Inc., the drugmaker that acquired Pharmasset Inc. last month for its experimental hepatitis C treatments, gained in extended trading after saying one of the therapies produced positive clinical trial results.
Patients with genotype 1 hepatitis C -- the most common in North America -- had no detectable signs of the virus after four weeks on the drug, PSI-7977, Norbert Bischofberger, Gilead’s chief scientific officer, said today on the Foster City, California-based company’s earnings call. An earlier study of the medicine, gained in the $10.8 billion Pharmasset purchase, cured all patients with genotype 2 and 3.
Drugmakers including Gilead, Merck & Co., Vertex Pharmaceuticals Inc. and Bristol-Myers Squibb Co., are striving to develop a new class of oral cures for hepatitis C to replace older drugs that require injections. Bristol-Myers recently agreed to spend $2.5 billion to buy Inhibitex Inc. for its experimental hepatitis C therapies.
“It looks like Gilead will race ahead and continue to lead because it’s drug 7977 continues to support potential 100 percent cure rates,” Michael Yee, an analyst with RBC Capital Markets in San Francisco, said in an interview. “The data disclosed in genotype 1, an important population for which there was no good data yet, continues to show they can support a multibillion-dollar drug franchise with 7977.”
The drug was tested in combination with ribavirin, a medication currently used in treating the disease. The therapy was given to patients who hadn’t taken other drugs and those whose illness wasn’t helped by other treatments.
The company will present further data on the clinical trial at an infectious diseases conference next month in Seattle.
Gilead rose as much as 6.4 percent to $52.45 after closing at $49.31 in New York trading.
--Editor: Andrew Pollack
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net